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临床试验/NCT06381804
NCT06381804已完成不适用

Effect of Shotblocker and Palm Stimulator in Reducing Pain Associated With Intramuscular Injection: A Randomized Controlled Trial

Necmettin Erbakan University2 个研究点 分布在 2 个国家目标入组 96 人开始时间: 2024年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Visual analog scale (VAS) pain Scale score

研究概览

简要总结

This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.

详细描述

It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the research,
  • Those who will receive vitamin B injection ordered by physician due to B12 deficiency,
  • Conscious and oriented,
  • Able to understand and speak Turkish,
  • Age range is between 18-65,
  • Having no vision or hearing problems,
  • Pain score of 2 or less when evaluated with a visual analog scale,
  • Able to lie in the right lateral position where injection can be administered,
  • Those who have not had an IM injection into the right ventrogluteal area in the last week,
  • Body mass index is within the normal range (25.0-29.9 kg/m2) according to WHO,
  • Those who have not used any analgesics or muscle relaxants in the last 24 hours,
  • Does not have any problems such as hardness, mass, edema or infection in the area to be injected,
  • According to his own statement, he has no psychiatric diagnosis,

排除标准

  • Having pain anywhere in the body,
  • Narcotic type or different analgesic area before application,
  • Pregnant or suspected of pregnancy,
  • Individuals in menstrual period,
  • Receiving chemotherapy and radiotherapy treatment,
  • Those who have migraine, are in the postoperative period, have nerve damage, neuropathy and a vascular disease,
  • Those who have disabilities in grasping their hands,

结局指标

主要结局

Visual analog scale (VAS) pain Scale score

时间窗: up to 6 weeks

The Visual analog scale (VAS) score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulden Basit

Assist. Prof.

Necmettin Erbakan University

研究点 (2)

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Effect of Shotblocker and Palm Stimulator | 临床试验